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FDA 510(k)

Brainance MD

K-Number: K202808 · 2021-10-14

Decision Date2021-10-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Brainance MD is the device name listed in this FDA 510(k) record. The listed applicant is Advantis Medical Imaging Single Member P.C.. It received FDA 510(k) clearance on 2021-10-14 under 510(k) number K202808. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Brainance MD?

Brainance MD is a medical device that received FDA 510(k) clearance on 2021-10-14. The listed applicant is Advantis Medical Imaging Single Member P.C.. The 510(k) number is K202808.

When did Brainance MD receive FDA 510(k) clearance?

Brainance MD received FDA 510(k) clearance on 2021-10-14, under 510(k) number K202808.

Who is the listed applicant for Brainance MD?

The FDA 510(k) record lists Advantis Medical Imaging Single Member P.C. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Brainance MD?

The FDA product code for Brainance MD is LLZ.

Other records listing Advantis Medical Imaging Single Member P.C. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.